GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS
GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS
Method of administration: A single semi occluded application of 0.5 mL of the neat test substance to intact skin; after 4 hours residual test substance was removed by gentle swabbing with liquid paraffin; A contralateral area of untreated skin served as the control site. Control sites were similarly swabbed. Test method: OECD TG 404 Dermal effects: Mean group score (24, 48 & 72 hour observation): No evidence of skin irritation was observed, all individual scores were zero. Erythema/eschar formation: 0.0 Oedema: 0.0 Result: C20-24 Alkenes, branched and linear was non irritating to the skin of rabbits. FULL PUBLIC REPORT 26 April 2000 NA/713 Page 48 of 100
9.1.5.8 Acute Dermal Irritation of Other Alkenes (HEDSET 1-Octadecene) The following data, unless otherwise indicated, are taken from HEDSET data sheets for 1dodecene 1-tetradecene 1-hexadecene and 1-octadecene. The full study reports were not provided in the submission. The HEDSET documents indicate these tests were not conducted in accordance with GLP or OECD or EC testing guidelines. In each case New Zealand white rabbits were administered single dermal doses of 10 g/kg of test substance. The results below represent application of the test substance to non-abraded skin. The HEDSET documents reported each of the test substances as non-irritating. Test Substance Mean group score (24, 48 & 72 hour observation) Erythema Oedema C12 - C26* Olefin/Paraffin H18 0.0 B 0.0 C14 – C16* Olefin H14 PDS = 1.2 B - C14 – C18* Olefin H18 PDS = 0.14 B - C14-C18* Olefin/Paraffin H18 0.0 B 0.0 C14 – C18* Olefin H14 PDS = 0.14 B - C14 – C18* Olefin/Paraffin H18 0.0 B 0.0 C14 - C26 olefin H14 PDS = 0.0 B - C14 – C26* Olefin/Paraffin H18 0.0 B 0.0 C16-C18 olefin H16 PDS = 0.2 B - 1-octadecene H18 1.2 AE 0.1 Neodene 18 alpha olefin H18 2.17 A (PII = 3.2) 0.94 SHOP alpha olefin C18 H18 1.2 A (PII = 1.3) 0.1 C18 – C24* Olefins H18 0.0 B 0.0 C18 – C26* Olefin/Paraffin H18 0.0 B 0.0 C18 – C30* Olefin/Alcohol H18 0.0 B 0.0 *Purity not specified. A – 4 hour exposure period. B – 24 hour exposure period. E – Erythematous reaction persisted to Day 14. At Day 16 the skin was dry and flakey. PDS – Primary Dermal Index Score. PII – Primary Irritation Index. H14 (EU 1995) H16 (EU 1995) H18 (EU 1995) FULL PUBLIC REPORT 26 April 2000 NA/713 Page 49 of 100
- Page 1 and 2: File No: NA/713 26 April 2000 NATIO
- Page 3 and 4: 3. PHYSICAL AND CHEMICAL PROPERTIES
- Page 5 and 6: Hydrolysis as a Function of pH: Dis
- Page 7 and 8: No definitive test results for the
- Page 9 and 10: 18 and are automatically discharged
- Page 11 and 12: esultant oil/water emulsion is pass
- Page 13 and 14: The results for a modified Sturm te
- Page 15 and 16: was also performed according to the
- Page 17 and 18: 9. EVALUATION OF TOXICOLOGICAL DATA
- Page 19 and 20: 9.1.2 Dermal Toxicity 9.1.2.1 Rabbi
- Page 21 and 22: 9.1.6.1 Rabbit/NZ White C12 - C16 A
- Page 23 and 24: 9.3.1.5 Chromosome aberration Human
- Page 25 and 26: Clinical observations: A few days a
- Page 27 and 28: LD50: > 5 000 mg/kg Result: C20-24
- Page 29 and 30: 9.1.1.7 Acute Oral Toxicity of Othe
- Page 31 and 32: hair at the treatment site. Morphol
- Page 33 and 34: Result: C20-24 Alkenes, branched an
- Page 35 and 36: 9.1.3 Inhalation Toxicity 9.1.3.1 A
- Page 37 and 38: FULL PUBLIC REPORT 26 April 2000 NA
- Page 39 and 40: Draize score abraded skins: Time af
- Page 41 and 42: 9.1.5.3 Acute Dermal Irritation of
- Page 43 and 44: Mean group score (24, 48 & 72 hour
- Page 45 and 46: 9.1.5.5 Acute Dermal Irritation of
- Page 47: Draize scores: Time after Animal #
- Page 51 and 52: Draize scores of non irrigated eyes
- Page 53 and 54: 9.1.6.3 Acute Eye Irritation of C16
- Page 55 and 56: Draize scores of irrigated eyes: Ti
- Page 57 and 58: 9.1.7 Skin Sensitisation 9.1.7.1 Sk
- Page 59 and 60: that sensitisation may have been in
- Page 61 and 62: Number of animals: 20 test animals,
- Page 63 and 64: liver parenchyma. Result: Repeated
- Page 65 and 66: Pathology: F0 males and satellite f
- Page 67 and 68: were observed at the end of the rec
- Page 69 and 70: negative control. The positive cont
- Page 71 and 72: increases in the incidence of aberr
- Page 73 and 74: Clinical observations: No mortality
- Page 75 and 76: hour observation and crust formatio
- Page 77 and 78: 10. ASSESSMENT OF ENVIRONMENTAL EFF
- Page 79 and 80: with 42% less growth (relative to t
- Page 81 and 82: 10.2 TESTS ON MARINE ORGANISMS Exot
- Page 83 and 84: 6.25% WAF 5 of the test animals had
- Page 85 and 86: NOEL (96 h) < 0.09 g/L FULL PUBLIC
- Page 87 and 88: the 48 hour NOEL was less than 1 90
- Page 89 and 90: 11. ASSESSMENT OF ENVIRONMENTAL HAZ
- Page 91 and 92: R65 - May Cause Lung Damage if Swal
- Page 93 and 94: 14. MATERIAL SAFETY DATA SHEET The
- Page 95 and 96: Gerarde, H. (1963) Toxicological St
- Page 97 and 98: Safepharm Laboratories Limited (199
9.1.5.8 Acute Dermal Irritation of Other Alkenes (HEDSET 1-Octadecene)<br />
The following data, unless otherwise indicated, are taken from HEDSET data sheets for 1dodecene<br />
1-tetradecene 1-hexadecene and 1-octadecene. The full study reports were not<br />
provided in the submission.<br />
The HEDSET documents indicate these tests were not conducted in accordance with GLP or<br />
OECD or EC testing guidelines.<br />
In each case New Zealand white rabbits were administered single dermal doses of 10 g/kg of<br />
test substance. The results below represent application of the test substance to non-abraded<br />
skin. The HEDSET documents reported each of the test substances as non-irritating.<br />
Test Substance Mean group score (24, 48 & 72 hour observation)<br />
Erythema Oedema<br />
C12 - C26* Olefin/Paraffin H<strong>18</strong> 0.0 B 0.0<br />
C14 – <strong>C16</strong>* Olefin H14 PDS = 1.2 B -<br />
C14 – C<strong>18</strong>* Olefin H<strong>18</strong> PDS = 0.14 B -<br />
C14-C<strong>18</strong>* Olefin/Paraffin H<strong>18</strong> 0.0 B 0.0<br />
C14 – C<strong>18</strong>* Olefin H14 PDS = 0.14 B -<br />
C14 – C<strong>18</strong>* Olefin/Paraffin H<strong>18</strong> 0.0 B 0.0<br />
C14 - C26 olefin H14 PDS = 0.0 B -<br />
C14 – C26* Olefin/Paraffin H<strong>18</strong> 0.0 B 0.0<br />
<strong>C16</strong>-C<strong>18</strong> olefin H16 PDS = 0.2 B -<br />
1-octadecene H<strong>18</strong> 1.2 AE 0.1<br />
Neodene <strong>18</strong> alpha olefin H<strong>18</strong> 2.17 A (PII = 3.2) 0.94<br />
SHOP alpha olefin C<strong>18</strong> H<strong>18</strong> 1.2 A (PII = 1.3) 0.1<br />
C<strong>18</strong> – C24* Olefins H<strong>18</strong> 0.0 B 0.0<br />
C<strong>18</strong> – C26* Olefin/Paraffin H<strong>18</strong> 0.0 B 0.0<br />
C<strong>18</strong> – C30* Olefin/Alcohol<br />
H<strong>18</strong><br />
0.0 B 0.0<br />
*Purity not specified.<br />
A<br />
– 4 hour exposure period.<br />
B<br />
– 24 hour exposure period.<br />
E<br />
– Erythematous reaction persisted to Day 14. At Day 16 the skin was dry and flakey.<br />
PDS – Primary Dermal Index Score.<br />
PII – Primary Irritation Index.<br />
H14<br />
(EU 1995)<br />
H16<br />
(EU 1995)<br />
H<strong>18</strong><br />
(EU 1995)<br />
FULL PUBLIC REPORT 26 April 2000<br />
NA/713 Page 49 of 100
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